Small Battery Drive II User Manual DePuy Synthes 3
Expected Clinical Benefits
Power Tools systems offer the following benefits to the
patient and health care professionals compared to a
manual approach:
•
Reduced effort to perform a surgery: The surgeon needs
less physical force during the surgical procedure.
•
Improved cutting speed and torque: This contributes to a
better outcome of the surgery compared to surgeries
without power tools.
•
Shorter surgery time: Using a power tool significantly
reduces the surgery time. This means reduced exposure
to anesthesia and less stress to the patient which sup-
ports recovery and wound healing.
•
Reproducible bone cutting and drilling: Bone cutting,
modeling, or drilling can be consistently performed over
time. Implants or bone segments can be fixed more
accurately. This contributes to a more consistent clinical
outcome of the surgery.
•
Potential Adverse Events
As with all major surgical procedures, risks, side effects and
adverse events can occur. While many possible reactions
may occur, some of the most common adverse events
include:
•
Systemic infection
•
Neurovascular injury
•
Thermal necrosis
Intended use
The Small Battery Drive II is designed for the use in
traumatology and orthopedic surgery of the skeleton, i.e.
drilling, reaming or cutting bone.
Intended user
The Small Battery Drive II is intended to be used by
qualified health care professionals e.g. surgeons, operating
room staff, and individuals involved in preparation of the
device.
Indications
The Small Battery Drive II system does not have any
product specific indications. Depuy Synthes manufactures
several surgical medical devices intended for preparing the
surgical site for acceptance of Depuy Synthes implants as
well as aiding in the implantation of devices. The
indications are based upon the implant devices rather than
the instruments. Specific indications for implants can be
found in the Depuy Synthes implant instructions for use.
Contraindications
The Small Battery Drive II system does not have any
product specific contraindications. Depuy Synthes
manufactures surgical medical devices intended for
preparing the site for acceptance of Depuy Synthes
implants as well as aiding in the implantation of devices.
The contraindications are based upon the implant devices
rather than the instruments. Specific contra indications for
implants can be found in the Depuy Synthes implant
instructions for use.
Patient Target Group
Depuy Synthes manufactures surgical instruments intended
to prepare the site and aide in implantation of Depuy
Synthes implants. The patient target group is based upon
the implant devices rather than the instruments. Specific
patient target group for the Implants can be found in the
respective Depuy Synthes implant instructions for use.
Introduction
General Information
Summary of Contents for DePuy Synthes Small Battery Drive II
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